Shortened vs standard chemotherapy combined with immunotherapy for the initial treatment of patients with Follicular Lymphoma

Phase 1

• Conditions: High tumor burden Follicular Lymphoma; MedDRA version: 24.0Level: LLTClassification code 10080213Term: In situ follicular lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2020-003277-22-IT
• Lead Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-22
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 602

Inclusion Criteria

1)Histologically documented diagnosis of CD20+ Follicular lymphoma grade 1-2 or 3a, according to WHO 2017;
2)Age = 18 years;
3)ECOG performance status 0-2;
4)No previous immunochemotherapy for the lymphoma (localized radiotherapy or rituximab monotherapy with max of 4 doses are allowed);
5)Ann Arbor stage II-IV;
6)High tumor burden as per GELF criteria;
7)At least one site of measurable nodal disease at baseline = 1.5 cm in the longest transverse diameter as determined by CT scan (MRI is allowed if CT scan cannot be performed); or evaluable disease at baseline FDG-PET scan (at least one metabolic active site of disease);
8)Adequate hematological counts (unless due to bone marrow involvement by lymphoma);
9)Adequate renal function defined as creatinine = 2 mg/dL, unless secondary to lymphoma;
10)Adequate hepatic function defined as bilirubin = 2 mg/dL, unless secondary to lymphoma;
11)LVEF > 50% at bidimensional echocardiogram (mandatory only for patients receiving R/G-CHOP);
12)Life expectancy = 6 months;
13)Subject understands and voluntarily signs an informed consent form;
14)Subject must be able to adhere to the study visit schedule and other protocol requirements;
15)Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 12 months after last rituximab dose or 18 months after last obinutuzumab dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 301
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 301

Exclusion Criteria

1)Histological diagnosis different from FL grade 1-3a WHO 2017 classification;
2)Suspect or clinical evidence of CNS involvement by lymphoma;
3)Contraindication to the use of anti-CD20 monoclonal antibodies;
4)Subject has received any anticancer therapy (chemotherapy, immunotherapy, investigational therapy, including targeted small molecule agents) within 14 days prior to the first dose of study drug;
5)Noteworthy history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent;
6)Any history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uterine; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; limited stage surgically removed breast cancer or adequately treated with radiation therapy; limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy; previous malignancy confined and surgically resected with curative intent;
7)Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
-Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;
-Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA;
8)Women who are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified